Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)
Leading Pharma, LLC
OPHTHALMIC
PRESCRIPTION DRUG
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5%timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14) ]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1) ]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventricul
Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is a sterile, isotonic, buffered, slightly viscous, aqueous solution. Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is supplied in a 5mL and 10 mL labeled translucent LDPE bottle with insert cap assembly comprising of a dark blue colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust-cover sealing the bottle cap. NDC 69315-305-05, 5mL in a 5mL bottle NDC 69315-305-10, 10 mL in a 10 mL bottle Storage Store Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP at 20° to 25°C (68° to 77°F). Protect from light. After opening, Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle.
Abbreviated New Drug Application
DORZOLAMIDE AND TIMOLOL - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SOLUTION LEADING PHARMA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION, FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL:1998 INDICATIONS AND USAGE Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1) DOSAGE AND ADMINISTRATION The dose is one drop of Dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily. (2) DOSAGE FORMS AND STRENGTHS Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP containing 20 mg/mL dorzolamide (2%) equivalent to 22.26 mg/mL of dorzolamide hydrochloride and 5 mg/mL timolol (0.5%) equivalent to 6.83 mg/mL of timolol maleate. (3) CONTRAINDICATIONS Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with: Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.(4.1) Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. (4.2) Hypersensitivity to any component of this product. (4.3, 5.3) WARNINGS AND PRECAUTIONS P Přečtěte si celý dokument